Automatic analyzer

ABSTRACT

An automatic analyzer is capable of performing analysis of a precision control sample in response to an external factor to alleviate the burden on the operator and surely performing precision control at appropriate timing at which precision control must be performed, thereby allowing automatic maintenance of the measurement precision. Analysis of a precision control sample is performed by creating an analysis request for the internally held precision control sample and then transferring the precision control sample in response to an external factor occurring, for example, when a calibrator is inputted in the analyzer, the number of remaining reagents under analysis satisfies a predetermined condition (becomes zero or falls below a specified value), the date changes, a specified time runs out, the operator is changed, the number of analyzed samples exceeds a specified value, a specified time period has elapsed, a new reagent is registered, a measurement failure is detected, etc.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an automatic analysis system whichperforms qualitative and quantitative analyses of a biological sample,such as blood, urine, etc. More particularly, the present inventionrelates to an automatic analysis system which is provided with atransfer system for transferring sample vessels to analysis system.

2. Description of the Related Art

There is a remarkable increase in the use of automatic analyzers whichautomatically perform qualitative and quantitative analyses of abiological sample, such as blood, urine, etc., mainly in large hospitalsand clinical inspection centers where it is necessary to processbiological samples of a number of patients in a short time. Varioustypes of automatic analyzers, i.e., large-, medium-, and small-sizedautomatic analyzers are under development in relation to the throughput.Particularly in the case of a certain large-sized analyzer whichperforms analysis of a number of samples, a sample vessel containing abiological sample is held in a holder, called sample rack, and thentransferred to a plurality of analyzers through a transfer line(transfer system). When an inspection engineer inputs the sample rackinto a sample rack input slot, the analyzer automatically performsprocessing up to output of analysis results.

In this case, the transfer line having a form of a belt conveyortransfers the sample rack inputted through the sample rack input slot, abar code reader provided in the middle of the transfer line recognizesthe rack type and sample, and then analysis is performed. As such anautomatic analysis system, a system disclosed for example inJP-A-10-325839 is known.

SUMMARY OF THE INVENTION

With such a large-scale system, it is necessary to maintain themeasurement precision (quantitative characteristics) of the system byplacing a calibrator and a precision control sample having knownconcentration, etc. and periodically performing analysis. The calibratorand precision control sample are analyzed according to the order inwhich they are inputted into the sample rack input slot. Further, sincenot all items (TP, GOT, and other analysis items) can be covered with asingle calibrator and a single precision control sample, measurement ofa plurality of calibrators and precision control samples is necessary.

With a medium- or small-sized automatic analyzer, a sample vesselstoring a sample under measurement is arranged on a disk-shaped sampledisk. Therefore, it is possible for the operator of the analyzer toperform calibration and precision control simply by inputtingmeasurement commands in the analyzer.

However, with a large-sized automatic analyzer for transferring racks byuse of a transfer line, it is necessary for the operator of the analyzerto install a sample rack mounting sample vessels for storing acalibrator and a precision control sample at the rack input unit of theanalyzer.

Therefore, if the operator does not input a rack mounting a calibratorand a precision control sample, calibration and precision control cannotbe performed.

In such a case, the operator needs to prepare a calibrator and aprecision control sample even during analysis of a general sample. Thismay prevent analysis of general samples which is a primary object of theanalyzer.

An object of the present invention is to provide an automatic analyzerthat can accomplish precision control even if the operator does notperform an operation of inputting a precision control sample.

A configuration of the present invention for accomplishing theabove-mentioned object will be explained below.

An automatic analyzer comprising: an analysis unit for analyzing abiological sample; a transferring mechanism for transferring a samplerack to the analysis mechanism and a sample rack (with sample dispensingcompleted) from the analysis mechanism; a sample supply unit whichsupplies a sample to the sample buffer; and a sample storage unit whichstores a sample from the sample buffer.

Although a typical transferring mechanism is structured such that aspace arranging racks moves by itself, such as a belt conveyer, or asample rack gripped by an arm or claw is slid on a base without move ofthe base, any transferring mechanism is possible as long as it isprovided with a physically movable sample rack.

There is provided a mechanism that can keep holding a precision controlsample inputted to the sample buffer.

There is provided a second sample provision unit that can keep holding aprecision control sample in each analysis unit.

When a precision control sample is kept internally holding, theautomatic analyzer according to the present invention is capable ofautomatically performing analysis of a precision control sample inresponse to an external factor, for example, when a calibrator isinputted in the analyzer, the number of remaining reagents satisfies apredetermined condition (becomes zero or falls below a specified value),the number of analyzed samples exceeds a specified value, a specifiedtime period has elapsed, etc. Accordingly, it is possible to easilyaccomplish precision control at appropriate timing, thereby alleviatingthe burden on the operator.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram showing an embodiment of an automatic analyzeraccording to the present invention.

FIG. 2 is a diagram showing an area which holds a precision controlsample of the automatic analyzer according to the present invention.

FIG. 3 is a diagram showing a screen for registering various setups foran internally held precision control sample in the automatic analyzeraccording to the present invention.

FIG. 4 is a diagram showing a processing flow when a precision controlsample to be held internally in the automatic analyzer according to thepresent invention.

FIG. 5 is a diagram showing a processing flow for performing precisioncontrol by use of a precision control sample to be held internally whena calibrator is inputted in the automatic analyzer according to thepresent invention.

FIG. 6 is a diagram showing a processing flow for performing precisioncontrol by use of a precision control sample to be held internally whenthe number of remaining reagents satisfies a predetermined conditionwhen reagents are used in the automatic analyzer according to thepresent invention.

FIG. 7 is a diagram showing a processing flow for performing precisioncontrol by use of a precision control sample to be held internally wheneach condition is satisfied in the automatic analyzer according to thepresent invention.

FIG. 8 is a diagram showing a processing flow for performing precisioncontrol by use of a precision control sample to be held internally whenmeasurement failure is detected in the automatic analyzer according tothe present invention.

FIG. 9 is a diagram showing a processing flow when an expiration date ofan internally held precision control sample has expired in the automaticanalyzer according to the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A configuration and operations of an automatic analysis system accordingto an embodiment of the present invention will be explained below withreference to FIGS. 1 to 9.

FIG. 1 is a diagram showing a general configuration of an automaticanalyzer according to an embodiment of the present invention.

The automatic analysis system according to the present embodimentcomprises: a sample rack input part 10; a sample rack storage part 11;an ID reader 12; a transfer line 13, a sample rack buffer unit 21;analysis modules 31 and 32; and management computers 1 and 2.

The sample rack input part 10 is used to input sample racks which holdssamples. The analysis modules 31 and 32 are arranged along the transferline 13 and removably connected to the transfer line 13. There may beany number of analysis modules. The present embodiment includes twoanalysis modules.

The transfer line 13 transfers a sample rack from the sample rack inputpart 10 to the analysis modules 31 and 32 according to an analysisrequest, transfers a sample rack holding a sample that has been analyzedby the analysis modules 31 and 32 to the sample rack buffer unit 21, ortransfers a sample rack not requested for analysis to the sample rackstorage part 11.

The sample rack buffer unit 21 provided in the transfer line 13, withwhich a rack storing a calibrator, a precision control sample, and ageneral sample are transferred, is a line mechanism that is capable ofholding one or more sample racks. The sample rack buffer unit 21 makesit possible to hold a rack holding any sample transferred from thetransfer line 13 for a desired time period and then resupply the samplerack to the analysis modules or the sample rack storage part 11 atdesired timing.

The sample rack input part 10 includes the management computers whichperform necessary control of the sample rack input part 10, the samplerack storage part 11, the ID reader 12, the transfer line 13, and thesample rack buffer unit 21. Further, a memory unit of the managementcomputer 1 for storing input/output information and a display unit 2 forinputting information and displaying analysis results are connected tothe management computers 1 and 2.

A sample held by the sample rack has a sample ID which indicatessample-related attribute information (receipt number, patient name,request analysis item, etc.) and further the sample rack has a rack IDwhich indicates rack identification information, such as the racknumber. The sample rack placed in the sample rack input part 10 istransferred by the transfer line 13. When the sample rack is moved onthe transfer line 13, the sample ID and the sample rack ID are read bythe ID reader 12 and then transferred to the total management computers1 and 2. The total management computers 1 and 2 determine an analysismodule that will analyze a requested analysis item based on theattribute information.

Although a sample mentioned here is typically serum which is liquidunder inspection, it is also possible to perform analysis with wholeblood or diluted liquid sample. Further, a sample rack means a rack inwhich one or more sample vessels for storing samples can be arranged. Asample vessel can be a test tube, a blood collecting vessel, or anyother vessels that can store a sample.

The following explains processing for internally holding a precisioncontrol sample in the automatic analysis system according to the presentembodiment, with reference to FIGS. 2, 3, and 4.

When a rack from the sample rack input part 10, the sample type isdetermined from the sample ID and the sample rack ID read by the IDreader 12.

In this case, if a recognized sample rack arranges a precision controlsample, if holding is set with setup of holding of precision controlsamples 111 a, if number of internally held precision control samples112 a is 1 or above, and if a precision control sample hold area 21 a isempty, the sample is held in the analyzer for each rack.

If the sample is not a precision control sample or if the setup isdisabled, the sample is subjected to normal analysis and then collectedin the sample rack storage part 11 as usual.

The following explains analysis of an internally held precision controlsample with input of a calibrator in the automatic analysis systemaccording to the present embodiment, with reference to FIG. 5.

As mentioned above, when the sample type is determined by the sample IDand the sample rack ID read by the ID reader 12, if the sample type isrecognized as a calibrator and if an effective precision control sampleis held in the analyzer, an analysis request for a predetermined item(for example, the same item) is created for an item to be analyzed witha calibrator in relation to the precision control sample.

After a calibrator is transferred, internally held precision controlsamples are transferred in succession and then measured.

If the sample is not a calibrator or if no effective precision controlsample is held, only the calibrator is subjected to normal measurementprocessing.

The above-mentioned analysis makes it possible to perform measurement ofa precision control sample based on a calibrator. Therefore, it becomespossible for the operator to omit the creation of an analysis requestfor a precision control sample and the preparation of a sample.

The following explains analysis of an internally held precision controlsample in relation to a waiting reagent in the automatic analysis systemaccording to the present embodiment, with reference to FIG. 6. With thepresent embodiment, assuming an automatic analyzer in which a waitingreagent is automatically selected when the number of remaining reagentscurrently being used becomes zero, the following explains a case wheremeasurement of a precision control sample is automatically performedwhen the number of remaining reagents falls below a threshold value.

With a rack holding a sample, which is assigned an analysis item andtransferred to the analysis modules 31 and 32, the sample will bedispensed in order to analyze the item.

At this timing, analysis of the item is started and, when reagents fromthe analysis modules 31 and 32 have been consumed, the update of thenumber of remaining analyzable reagents is reported and then the totalmanagement computers 1 and 2 update the number of analyzable reagents.

In this case, if it is determined that the updated number of remaininganalyzable reagents falls below the number of remaining analyzablereagents designated in Waiting reagent analysis condition 112 c at thistime, if a reagent that can be replaced in relation to the inspectionitem is waiting, and if there is an internally held precision controlsample, a predetermined analysis request is created in relation to aninternally held precision control sample, the internally held precisioncontrol sample is transferred, and analysis is performed.

If the updated number of remaining analyzable reagents does not fallbelow the number of remaining analyzable reagents designated in Waitingreagent analysis condition 112 c, if no reagent that can be replaced inrelation to the inspection item is waiting, or if there is no internallyheld precision control sample, analysis of the precision control sampleis not performed.

This makes it possible to perform measurement of the precision controlsample immediately before the waiting reagent is selected, therebymaking it easier to maintain the measurement precision of the inspectionitem.

The following explains analysis on each condition with an internallyheld precision control sample in the automatic analysis system accordingto the present embodiment, with reference to FIG. 7.

If the date changes when setup of measurement at change of date hid isenabled, if specified time 112 e 1 or 112 e 2 runs out when setup ofmeasurement at specified time 111 e 1 or 111 e 2 is enabled, if theoperator is changed when setup of measurement at change of operator 111f is enabled, if time interval 112 g has elapsed since the lastmeasurement time when setup of measurement at time intervals 111 g isenabled, if the number of patient samples that has been measured sincethe last measurement of precision control exceeds number of samples 112h when setup of measurement by the number of samples 111 h is enabled,if a new reagent is registered when setup of measurement at registrationof new reagent 111 k is enabled, or if an analytical curve is manuallychanged when setup of measurement at manual change of analytical curve111 l is enabled, a predetermined analysis request is created, aninternally held precision control sample is transferred, and analysis isperformed.

This makes it possible to perform measurement of a precision controlsample under each condition. Therefore, it becomes possible for theoperator to perform measurement of a precision control sample atappropriate timing without creating a request for a precision controlsample and preparing a sample.

The following explains analysis with different internally held precisioncontrol samples based on failure detection at the time of precisioncontrol measurement in the automatic analysis system according to thepresent embodiment, with reference to FIG. 8.

If the precision control sample itself is deteriorated at the time ofmeasurement of a precision control sample, the concentration may havechanged and accordingly measurement results may indicate an abnormalvalue. In this case, if another precision control sample is held in theanalyzer, which allows analysis of a requested item with which anabnormal value is detected with the precision control sample, when setupof measurement with different sample at failure detection 111 j isenabled, the requested item is created for another internally heldprecision control sample, the precision control sample is transferred,and analysis is performed.

This makes it possible to determine whether the measurement item withabnormal value detection is really abnormal or the precision controlsample itself with abnormal value detection is deteriorated.

The following explains expiration date control of an internally heldprecision control sample in the automatic analysis system according tothe present embodiment, with reference to FIG. 9.

Generally, a precision control sample is provided with an expirationdate. When the expiration date has expired, some components of thesample may vary making it impossible to acquire an expectedconcentration value. This is why it is necessary to provide and controlan expiration date for the sample. The expiration date depends oncomponents, i.e., samples.

Further, since some samples are subjected to a few component variations,it is also assumed that a sample may have been consumed before componentvariation occurs while it is internally held. Therefore, it is alsopossible to make setting so as not to perform expiration date control.

The time when a precision control sample is stored in the managementcomputers 1 and 2, and when the present time exceeds Precision controlsample expiration date 112 i, the precision control sample is disabledso as to be unusable. Subsequently, it becomes possible to inhibitanalysis with a deteriorated precision control sample by making theprecision control sample unusable.

Although the above has explained a case of an automatic analyzer inwhich a precision control sample is internally held by arranging it in arack, similar control applies also to a case where a precision controlsample is provided in the second sample provision unit of each analysisunit.

If the operator prepares a precision control sample in advance, itbecomes possible to perform analysis of the precision control sample inresponse to an external factor, thereby alleviating the burden on theoperator. Further, it becomes possible to surely perform precisioncontrol at appropriate timing at which precision control must beperformed, thereby allowing automatic maintenance of the measurementprecision.

1. An automatic analyzer comprising: an analysis unit for analyzing asample; a rack transfer system for transferring a sample rack arranginga sample vessel which holds a sample to the analysis unit; a rack inputslot for inputting a sample rack to the rack transfer system; and amechanism for internally holding a precision control sample in theanalyzer, the precision control sample being provided in the samplerack; wherein the automatic analyzer includes control means forcreating, when a calibrator in the analyzer, a predetermined measurementrequest according to a requested item of the calibrator in relation tothe precision control sample and then transferring an internally heldprecision control sample so as to be analyzed after the calibrator. 2.An automatic analyzer comprising: an analysis unit for analyzing asample; a rack transfer system for transferring a sample rack arranginga sample vessel which holds a sample to the analysis unit; a rack inputslot for inputting a sample rack to the rack transfer system; and amechanism for internally holding a precision control sample in theanalyzer, the precision control sample being provided in the samplerack; wherein a plurality of reagents associated with the same item canbe arranged and, when the reagent currently being used has satisfied afirst predetermined condition, another waiting reagent can beautomatically selected; and wherein the automatic analyzer includescontrol means for creating a measurement request for a precision controlsample in relation to a waiting reagent and then transferring aninternally held precision control sample so as to be analyzed, when thenumber of remaining reagents currently being used has satisfied a secondpredetermined condition.
 3. An automatic analyzer comprising: ananalysis unit for analyzing a sample; a rack transfer system fortransferring a sample rack arranging a sample vessel which holds asample to the analysis unit; a rack input slot for inputting a samplerack to the rack transfer system; and a mechanism for internally holdinga precision control sample in the analyzer, the precision control samplebeing provided in the sample rack; wherein the automatic analyzerincludes control means for creating a predetermined measurement requestaccording to an internally held precision control sample and thentransferring the precision control sample so as to be analyzed, whenchange of the date has been recognized. 4-24. (canceled)